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A Pivotal, Multicenter, Blinded, Sham Procedure-Controlled Trial of Renal Denervation by the Peregrine System™ Kit, in Subjects With Hypertension (TARGET BP I)
The TARGET BP I Trial is a randomized, blinded, multi-center, international, sham-procedure controlled trial, comparing renal denervation performed with the Peregrine System Kit in the treatment group to the sham control group (without renal denervation - no alcohol infusion). Subjects will be randomized in a 1:1 fashion to treatment versus sham control via central randomization.
Details
| Lead sponsor | Ablative Solutions, Inc. |
|---|---|
| Phase | Phase 3 |
| Status | ACTIVE_NOT_RECRUITING |
| Enrolment | 300 |
| Start date | 2019-07-22 |
| Completion | 2026-05 |
Conditions
- Hypertension
Interventions
- Dehydrated alcohol
- Peregrine System Kit (Sham Procedure)
Primary outcomes
- Change in mean systolic ABPM — 3 months
The change in mean 24-hour ambulatory SBP from baseline to 3 months post-procedure
Countries
United States